Study on the Efficacy Mechanism of Natural Psychotherapy for Neurosis

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Natural Psychotherapy; Behavioral: Mental Health Education

• Registration Number: NCT05552014
• Lead Sponsor: Beijing HuiLongGuan Hospital

Brief Summary

explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

Detailed Description

1. To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.

2. Investigate the pathological mechanism of neurotic patients from the aspects of EEG/fMRI and biology.

3. To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• were between 16 and 55 years old;
• were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
• had an illness duration of at least 12 months;
• were able to participate in the entire trial and face-to-face on-site assessment

Exclusion Criteria

• pregnant or breastfeeding;
• suffered from organic brain diseases or severe physical illness;
• had a history of substance or alcohol abuse
• were at high risk of suicide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural Psychotherapy	Natural Psychotherapy	Intervention using natural psychotherapy for OCD patients for two to three hours once a week for eight weeks
Mental Health Education	Mental Health Education	Mental health education was given to another group of OCD patients for two hours once a week for eight weeks

Primary Outcome Measures

Name	Time	Method
Obsessive-compulsive symptoms	Baseline, week 4, week 8	Using the score of Yale-Brown Obsessive-Compulsive Scale as the primary outcome, a decrease in score of ≥35% was considered a 'response to treatment', also referred to as a 'full response', and a decrease in score of ≥25% was considered a 'partial response'

Secondary Outcome Measures

Name	Time	Method
Self-reported obsessive-compulsive symptoms	Baseline, week 4, week 8	The reduction rate of the score of Obsessive-Compulsive Inventory-Revised (OCI-R), a self-rating scale of OCD symptoms severity, was employed as a secondary outcome
Cognitive inhibition	Baseline, week 8	Cognitive inhibition was assessed using the emotional color-word Stroop task. The emotional Stroop task is a type of being Widely used cognitive inhibition assessment tools. The longer the reaction time, the worse the cognitive inhibition ability.
Behavioral inhibition	Baseline, week 8	Behavioral inhibition was assessed using the emotional stop signal task (SST). The emotional SST task is a type of being Widely used behavioral inhibition assessment tools. Among them, the greater the SSRT, the worse the behavioral inhibition ability.
ERP components associated with cognitive function	Baseline, week 8	To explore the ERP component analysis related to cognitive inhibition and Behavioral inhibition in obsessive-compulsive disorder (OCD) by event related potential (ERP) analysis
rest fMRI in Obsessive-compulsive patients	Baseline, week 8	The changes of resting-state functional connectivity were analyzed in patients with OCD before and after intervention. Resting-state functional connectivity：FC(Functional connectivity). Resting-state functional brain imaging data were collected using a GE 3.0T magnetic resonance scanner (GE Discovery MR750) at the Brain Imaging Center, Institute of Psychology, Chinese Academy of Sciences.

Trial Locations

Locations (2)

Anhui Mental Health Center; 🇨🇳 Hefei, Anhui, China

Institute of Psychology, Chinese Academy of Sciences; 🇨🇳 Beijing, China